A Non-Interventional Post-Authorization Safety Study (PASS) for Active Safety Surveillance of Recipients of the Pfizer-BioNTech COVID-19 mRNA vaccine in the EU

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47010
• EU PAS number:
  EUPAS41302
• Study ID:
  47010
• Official title and acronym:
  A Non-Interventional Post-Authorization Safety Study (PASS) for Active Safety Surveillance of Recipients of the Pfizer-BioNTech COVID-19 mRNA vaccine in the EU
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Spain
• Study description:
  This prospective, observational cohort study is a multi-center, non-interventional post-authorization safety study conducted to evaluate safety of study participants receiving the Pfizer-BioNTech COVID-19 mRNA vaccine. The study period is 30 months. Each participant will be followed from baseline (vaccination dose received at index date, where index date is defined as the date of Pfizer-BioNTech COVID-19 mRNA vaccine dose received within the 5 days prior to enrolment, regardless of dose number) until death, withdrawal of consent, loss to follow-up, 24 months or end of study period, whichever occurs first. Data will be collected at baseline directly from the participants receiving the vaccine and/or their designee, this may include a health care provider (HCP) or study staff at the site administering the vaccine. This study will collect information on all reported occurrences of the medically attended safety events of interest, which is based on the adverse events of special interest lists specified by ACCESS and SPEAC/Brighton Collaboration, for which the participant sought medical care during the study period. Data collection will be performed at baseline (vaccination dose received at index date) and at weeks 1, 2, 4, 6, 8, 12 and every three months thereafter, through 24 months following index date. In addition, data will be collected on any subsequent vaccine doses received during the study period. Participant reported medically attended safety events of interest will be confirmed by the treating HCPs or through medical record documentation if needed to validate or establish the diagnosis associated with the event and validate the occurrence of a safety event of interest, or other clinically significant event. This primary data collection study will aim for up to 10,000 vaccine recipients with 2 years of follow-up data from a total of approximately 20 centers. The study will be conducted in Germany, Italy and Spain.
• Study status:
  Finalised

Research institution and networks

Institutions

Pfizer

IQVIA

United Kingdom

Networks

Self Care Catalysts

Study timelines

Date when funding contract was signed

Planned: 27/10/2020

Actual: 27/10/2020

Study start date

Planned: 31/08/2021

Actual: 28/09/2021

Date of final study report

Planned: 30/09/2024

Actual: 10/05/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4591010_FINAL APPROVED PROTOCOL_20MAY2021

Updated protocol

C4591010_PROTOCOL AMENDMENT 2_07JAN2022

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)